PHARMACOECONOMICS INTRODUCTION IN THE CREATION OF POSITIVE DRUG LIST IN BULGARIA
Author(s)
Petrova G. I GIP1, Benisheva TVB2, Ivanova AD1, 1 Faculty of Pharmacy, Sofia, Bulgaria; 2 Ministry of Health, Sofia, Bulgaria
Presentation Documents
OBJECTIVES: To analyze the effect of the introduction of pharmacoeconomics evaluations in the creation of a positive drug list in Bulgaria. METHODS: Legislation analysis of the current regulation for the creation of positive drug lists and its impact on the number of medicines proposed for reimbursement and included in the list. RESULTS: Regulation for the creation of positive drug lists was issued in 2002 in Bulgaria with the aim to establish clear criteria for the selection of medicines for the reimbursement practice and decrease the number of reimbursed drugs. The medicines were separated into three main classes – originators; medicines for which there is a therapeutic alternative but which have higher efficiency or less adverse drug events, and generic medicines. For the first two groups, producers were asked to prepare pharmacoeconomic evaluation following previously established form. Out of the 3500 dosage forms registered in the country as prescription medicines, 2852 dossies were submitted, of which 2477 dosage forms were included in the positive drug list (550 INN). Originators account for 63%, imported generics for 19% and domestic generics for 18%. Excluded medicines compose 45% originators, 20% imported generics, 18% domestic generics. In comparison with previously existing drug lists, the number of drugs did not decrease significantly. Main difficulties during the evaluation process were lack of pharmacoeconomics analysis within the country, lack of national pharmacoeconomic guidelines and changes in the companies pricing policy. CONCLUSIONS: The introduction of pharmacoeconomic evaluation during the process of the creation of a positive drug list in Bulgaria did not decrease the number of selected medicines but stimulate companies to start developing evaluations within the country.
Conference/Value in Health Info
2004-10, ISPOR Europe 2004, Hamburg, Germany
Value in Health, Vol. 7, No. 6 (November/December 2004)
Code
PHP16
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases